Global Regulatory Affairs Lead — Medical Devices
Bioventus LLC
Bioventus LLC in Durham, North Carolina is seeking a Senior Regulatory Affairs Specialist to provide regulatory support for product marketing approvals and renewals. The role includes managing submissions and representing Regulatory during audits. The ideal candidate will have a Bachelor’s Degree in Life Sciences or Engineering and at least 5 years of experience in Regulatory Affairs within the medical device industry. Strong communication and organizational skills are essential. #J-18808-Ljbffr Bioventus LLC
Vacancy posted 4 days ago
Similar jobs that could be interesting for youBased on the Global Regulatory Affairs Lead — Medical Devices in Durham, NC vacancy
- Bioventus LLC is seeking a Senior Regulatory Affairs Specialist in Durham, NC. This role involves authoring and submitting regulatory applications for product clearance, maintaining registrations, and ensuring compliance with relevant regulations. The ideal candidate holds...Medical device
- A leading medical device company located in Durham, NC is seeking a Regulatory Affairs Manager. This role is responsible for developing and executing global regulatory strategies to ensure compliance with various national and international regulations. Candidates should...Medical device
- Bioventus LLC. is seeking a Senior Regulatory Affairs Specialist in Durham, NC. In this hybrid role, you will author and submit key regulatory... ...to 25% of the time. Join Bioventus and make a difference in helping patients lead active lives. #J-18808-Ljbffr Bioventus LLC.Medical device
- SunTech Medical, Inc. in Morrisville is seeking a Senior Buyer to lead procurement for global product lines and manage supplier relationships. This role demands strategic thinking... ...hands-on execution in a fast-paced medical device environment. The ideal candidate will have...Medical device
- ...Carolina, is seeking a Senior Buyer to lead procurement for global product lines and manage supplier... ...strategic initiatives in a regulated medical device environment. The ideal candidate... ...supply chains, ensuring compliance with regulatory standards, and collaborating with...Medical device
- ...option. Who You Are The Manager, Global GMP Compliance is responsible... ...(cGMPs), applicable regulatory requirements, and UTC requirements... ...agency requirements. Lead implementation, maintenance,... ...the biotech, pharmaceutical, medical device, biologics, or related regulated...Medical deviceWork from home
- Align Technology, Inc. is seeking a Global QMS Engineer to join their Quality department. This dynamic role will involve shaping Align... ...years of experience in Quality Management Systems within the medical device industry, and strong expertise in ISO standards. This position...Medical device
- ...Carolina Country United States Job Description Lead Quality/GxP Auditor Responsibilities:... ...that training solutions are aligned to global strategy where appropriate by... ...experience within the Pharmaceutical / Biotech / Medical Device industry Experience working in a GxP (...Medical deviceContract workWork experience placement
- ...Procurement Coordinator located in Durham, NC. This role focuses on strategic sourcing and supply chain management within the medical devices industry. The ideal candidate will have a Bachelor's Degree and a minimum of 5 years experience in procurement, with strong analytical...Medical deviceContract work
- ...Sr. Regulatory Affairs Specialist page is loaded## Sr. Regulatory Affairs Specialistlocations:... ...goals and rewards. Join a diverse team of global colleagues driven to help patients... ...Regulatory Affairs, preferably in the medical device industry.* FDA, EU, Health Canada, Brazil...Medical device
Bioventus
Durham, NC1 day ago - ...Regulatory Affairs Manager page is loaded## Regulatory Affairs Managerlocations... .... Join a diverse team of global colleagues driven to help... ...Engineering and Operations, Clinical/Medical Affairs, and other... ...required. Class II medical device experience required, Class III...Medical device
Bioventus
Durham, NC1 day ago - ## Senior Regulatory Affairs SpecialistApplylocations: Durham, NCtime type: Full timeposted... ...rewards. Join a diverse team of global colleagues driven to help patients... ...regulatory affairs position within the medical and/or diagnostic device industry.Must have 3 years of...Medical deviceWork at office
Bioventus
Durham, NC2 days ago - ...hybrid role focuses on leadership, strategy, and ensuring compliance for medical device excellence. You will guide a team in improving quality processes and automation while maintaining regulatory standards. Strong collaboration and quality assurance expertise are essential...Medical device
- Position Senior Regulatory Affairs Specialist - Durham, NC - Bioventus LLC. Responsibilities... ...maintain existing registrations globally. Author and maintain Technical... ...affairs or related role within the medical and/or diagnostic device industry. 3+ years of experience with...Medical deviceWork at officeRemote work
- ...Control, Compliance & Training Manager in Durham, NC. This hybrid role involves leading the design and improvement of Global Patient Safety training programs, ensuring compliance with regulatory requirements, and supporting quality control activities. The ideal candidate...
- A leading technology firm is seeking a Global Trade Compliance Manager to ensure adherence to international import/export laws. The ideal candidate will manage trade compliance programs and provide guidance on regulations like EAR and ITAR. Responsibilities include monitoring...
$93.1k - $232.8k
IQVIA Argentina, located in Durham, is seeking a Post-Trial Access Manager to oversee multiple global PTA programs. This role includes managing timelines, budgets, and compliance with regulations while serving as the primary contact for these programs. The ideal candidate...Full timeWork from home- US01 Wolfspeed, Inc. in Durham, North Carolina is seeking a Head of Global Tax to lead the tax accounting function, including ASC 740 compliance and tax return preparations. This role requires strong expertise in corporate income tax and will involve overseeing tax initiatives...
$235k - $255k
...manage a team delivering data-driven insights. The position is fully remote and offers opportunities for leadership development in a global context, alongside a competitive salary range of $235,000 to $255,000, plus bonus potential and comprehensive benefits. #J-18808-...Remote job$93.5k - $121k
..., and act swiftly to impact global eye health. We foster an inclusive... ...to hire a Sr. Associate II, Regulatory Affairs Strategy . This role is part... ...for Alcon's Intraocular Device portfolio, including... ...advantage. Support products in the medical device families, ensuring...Medical deviceRelocationFlexible hours- ...to ensure compliance with pharmaceutical, biotechnology, and medical device safety and efficacy guidelines. With offices in Caguas, PR, Boston... ...& San Francisco, CA and we serve life sciences clients in six global markets: United States, Puerto Rico, Dominican Republic,...Medical deviceFor contractors
- ...Compliance team. The successful candidate will ensure partner adherence to compliance standards, focusing on partner risk management globally. Responsibilities include developing compliance programs, conducting risk assessments, and delivering training. This role operates...Work at office3 days per week
- ...lives of millions of people? Grifols is a global healthcare company that since 1909 has... ...and regions. Summary Plasma Regulatory Affairs oversees the licensing, surveillance,... ...licensure and registration (biologics (BLA), medical device), Health Canada licensing, Clinical...Medical deviceWork at office
- Alcon is seeking a Sr. Associate II, Regulatory Affairs Strategy to ensure compliance for innovative intraocular devices. This onsite role includes coordinating regulatory submissions, conducting independent research, and driving competitive advantage through regulatory...Medical device
- ...candidate will manage the Invisalign QMS and ensure compliance with regulatory standards while promoting a culture of quality excellence... ...possess a master's degree and extensive experience in the medical device industry, combined with substantial leadership in quality systems...Medical device
- ...business partners across commercial, medical, market access, health outcomes at global, regional and country level will... ...Boards) as well as sponsoring or leading strategic projects to build and extend... ...to pharmaceuticals, medical device, or diagnostics at Affiliate/Regional...Medical device
GSK LLP
Durham, NC1 day ago - ...Job Title: Director, Regulatory Affairs Department: Pharmaceutical Development About Pelthos... ...Affairs develops, implements, leads and supports regulatory strategies for... ...understanding of other medicinal products such as medical device requirements. ~ Ability to think...Medical deviceWork at officeLocal area
Pelthos Therapeutics
Durham, NC3 days ago $173.2k - $272.6k
...Sterility Assurance (MQSA) provides global leadership for microbiology-... ...subject matter expert, and leads cross-site initiatives to... ...external sites. Identify regulatory requirements, cGMP... ...biopharmaceutical, vaccine, or medical device industry; OR M.S. with eight...Medical deviceFor contractorsMerck Gruppe - MSD Sharp & Dohme
Durham, NC1 day ago- ...to ensure compliance with pharmaceutical, biotechnology, and medical device safety and efficacy guidelines. With offices in Caguas, PR, Boston... ..., MA & San Francisco, CA and we serve life sciences clients in six global markets: United States, Puerto Rico #J-18808-Ljbffr...Medical device
Mentor Technical Group
Durham, NC4 days ago $90k - $100k
...Occupational health and safety management Medical device quality systems Manufacturing or other... ..., ISO 45001, and/or ISO 13485 Completed Lead Auditor training for ISO 9001, ISO 14001... ...external auditors Multi‑site, corporate, or global management system oversight experience...Medical devicePermanent employmentFull timeContract workFreelanceLocal areaTUV SUD AMERICA, INC.
Durham, NC17 hours ago
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Global Regulatory Affairs Lead — Medical Devices. Be the first to apply!
Related searches